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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K253545
Device Name Vulcan Spinal System
Applicant
K2m,Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact Tee Pamon
Correspondent
K2m,Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Correspondent Contact Tee Pamon
Regulation Number888.3070
Classification Product Code
NKB  
Date Received11/14/2025
Decision Date 02/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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